Stakeholders' Knowledge, Attitudes and Practices to Pharmacovigilance and Adverse Drug Reaction Reporting in Clinical Trials: a Mixed Methods Study

Overview

Journal Eur J Clin Pharmacol

Specialty Pharmacology

Date 2020 Jun 9

PMID 32507924

Citations 1

Authors

David O Riordan

Mary Kinane

Kieran A Walsh

Frances Shiely

Joe Eustace

Margaret Bermingham

Affiliations

Soon will be listed here.

Abstract

Purpose: The purpose of this study was to explore the knowledge, attitudes and practices of health professionals working in clinical trials, to pharmacovigilance and adverse drug reaction (ADR) reporting.

Methods: A mixed methods study comprising an online questionnaire disseminated from September to November 2018, three semi-structured interviews and four focus groups. The qualitative components were conducted with a random sample of questionnaire participants who had provided their contact details (n = 24). The qualitative interviews were conducted at a location convenient to the participant's place of work between October and December 2018.

Results: One hundred forty-eight participants completed the questionnaire. Study coordinators/project managers represented the largest group of participants ( 28.6%, n = 38). Poor knowledge or understanding of ADR reporting was the most frequently cited barrier to ADR reporting (75%, n = 93). The most common enabler to reporting was having a clear understanding of an ADR definition (85.7%, n = 108). Focus group and interview participants described having limited staff as a barrier to reporting an ADR. They welcomed the prospect of pharmacovigilance training and indicated that face-to-face training would be preferred to provision of online training.

Conclusion: This study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff.

Citing Articles

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